diapro, inc. ( – FDA Warning Letter

The FDA issued a Warning Letter to Diapro, Inc. (dba Diapro USA Inc) on October 17, 2008, following a review of their website, www.diaprousa.com. The FDA determined that the product "Diapro All Natural PentosePlus" is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), due to therapeutic claims for the cure, mitigation, treatment, or prevention of disease.

Violations include claims such as "decrease in hemoglobin Alc levels" and "decrease in blood sugar levels," and statements from an article titled "Eating pumpkins helps diabetics" suggesting the product can repair pancreatic cells, boost insulin, and reduce insulin needs for diabetics. Testimonials on the website also make disease claims, including lowering blood sugar, reducing insulin use, and reversing Type 2 diabetes. Metatags like "diabetes medicine" and "insulin" further support the intended drug use.

The FDA states that "Diapro All Natural PentosePlus" is a new drug under section 201(p) of the Act because it is not generally recognized as safe and effective for its promoted uses. Marketing this product without prior FDA approval, as required by section 505(a), is illegal. Additionally, the product is misbranded under section 502(f)(1) of the